TL12: Statistical Issues in the Approval of Biosimilars
View Presentation View Presentation
*Eric M Chi, Amgen Inc. 

Keywords:

Draft guidances for the approval pathway of biosimilars from the FDA have been released in February 2012. The decision rules, hence statistical methods, for the approval of biosimilars are of critical importance. Statistical issues, some may be particular to biological products, for the assessment of biosimilarity will be identified and discussed.